Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients

Authors: Nicolas M. Van Mieghem, G. Michael Deeb, Lars Søndergaard, Eberhard Grube, Stephan Windecker, Hemal Gada, Mubashir Mumtaz, Peter Skov Olsen, John Heiser, William Merhi, Neal S. Kleiman, Stanley Chetcuti, Thomas G. Gleason, Joon Sup Lee, Wen Cheng, Raj Makkar, Juan A. Crestanello, Barry George, Isaac George, Susheel Kodali, Steven J. Yakubov, Patrick W. Serruys, Rüdiger Lange, Nicolò Piazza, Mathew Williams, Jae K. Oh, David Adams, Shuzhen Li, Michael J. Reardon, SURTAVI Trial Investigators, Christopher B. Gitter, Karen Meyer, Dana Roberts, Richard Bae, Paul Sorajja, Benjamin Sun, Judah Askew, Frazier Eales, Thomas Flavin, Mario Goessl, Vibhu R. Kshettry, M. Mooney, Wesley R. Pedersen, Anil Poulose, Pezhman Roohani, Robert Saeid Farivar, Richard Shronts, R Tarrel, Mark Young, Eddy Butkus, Kristin Pendleton, Robert D. Fry, Carl Heine, Kristin La Roe, Trung Tin Tran, Laura Weig, Himanshu Agarwal, Thomas Langdon, Ruby Satpathy, John Batter, Karen Bremer, Unajyothi Indukuri, Marijke Baas, Corry Oomes-Sistermans, Manola Smits, Carien Coenen, Inge Driesen, Lia Lauryssen, Margreet Poorter, Jeroen Schaap, Mohamed Bentala, Peter den Heijer, Jan Pieter, Michel Remmers, Marie Story, Paul M.M. van Erven, H Verbiest, Jeroen Vos, Michelle Bennett, Wendy Dunaj, Deborah Seaton, Deborah A. Waller, Bijoy K. Khandheria, Tanvir Bajwa, Daniel O’Hair, Arshad Ahmed, Suhail Allaqaband, Ayman Gheith, Elizabeth Marriott, Ajaz Qhavi, Varun Kumar Saxena, Akram Shhadeh, Paul Werner, Christine Yeomans, Lynn Bessette, Jessica Byrne, Heather Kieckhefer, Marleny Munoz, Elizabeth Russo, Jason Klein, Michael M. Morgan, Timothy Byrne, Michael Caskey, Orazio Amabile, Kevin P. Brady, Steven Chung, Kelly Dacanay, Hao Fang, Douglas Franz, Claire Kelly, Akil Loli, Jeremy Payne, Ashish Pershad, Norman C. Wang, Jessi Lott, C. Angele Pool-Owens, Charlotte M. Porter, Jeffrey A. Hennan, H. Edward Garrett, Basil Paulus, J. Cymerman Craig, Lucas Elijovich, Joseph Samaha, Bradley A. Wolf, Lance Wright, Gilbert J. Zoghbi, Leslie Willcott, Brad Roberts, Robert F. Hebeler, Robert Stoler, Dion Graybeal, Paul Grayburn, Carl Ferdinand Howard Henry, Osman Mir, Ravi C. Vallabhan, Matthew Fanous, Jenifer Kaufman, James D. Chang, Warren J. Manning, Marilyn F. Riley, Kamal R. Khabbaz, Roger J. Laham, Jeffrey J. Popma, David F. Burke, Louis R. Caplan, Shing Fung Chui, Kim Guibone, S. Sendil Kumar, Vasileios‐Arsenios Lioutas, David Liu, Senthil Nathan, Duane S. Pinto, D. Eric Searls, Susan G. Fisher, Lindsay Guirgues, Sue Henderson, Laura Ashley Loving, Nicole McWalters, Kelly Patterson, Jesse Burkart, Bryan Carcedo, Russell Stacey, Mark Bladergroen, D. Scott Lim, Supakunya Edmonson, Stacey Epps, Marc Katz, Ken Ng, Amandeep Sangha, Jennifer Aucoin, Monique Roberts, Jaime Aubin, Callie Hotard, Michelle Tassin, Peter Fail, Edgar Feinberg, Donald Netherland, Richard Abben, Mohamad Allam, Michael Bates, Richard Dearman, Donald Gervais, Edward Haight, Michael Metes, Jeanette Naquin, Victor Tedesco, Lisa Thibodeaux, Karen Thompson, Sally Aberle, Dana Amaro, William Grey, Geoffrey Rose, M. Schérer, Michael Rinaldi, Eric Skipper, Charles R. Bridges, William Downey, Phaniraj Iyengar, Jerry L. Martin, Liam Ryan, Robert M. Stiegel, John S. Story, Khaled Alsabaawi, Mitch Gheorghiu, Chetana Singh, Jason Yashar, Robert J. Siegel, Wen Cheng, Raj Makkar, Karen Altman, Hasan Jilaihawi, Saibal Kar, Stephanie Khouw, Cyrus C. M. Mody, Danny Ramzy, Tracey Salseth, Jasminka Stegic, Alfredo Trento, Rosa Lazarte, Jeanie Sohn, Rebecca T. Hahn, Omar Khalique, Isaac George, Susheel Kodali, Mathew Williams, Marco Gonzalez Castellon, Jose Gutierrez Contreras, Tomoko Kitago, Benjamin Kummer, Tim Lekic, Eliza C. Miller, Yoshifumi Naka, Tamim Nazif, Abid Qureshi, Sara Rostanski, Craig R. Smith, Joshua Z. Willey, Shadi Yaghi, Leana Abreu, Emerson Clement, Sajjad Sabir, Janah Aji, Frank W. Bowen, Georges Kaddissi, Thomas Mirsen, Muhammad Muntazar, Jeffrey Ogbara, Michael Rosenbloom, W Schell, Ryna Then, Heidi Carl, Hong Huang, Ghassan Kreydi, Heather Wolak, Gregory Sandidge, Omar Ali, Zewditu E. Asfaw, Scott P. Henry, Ali Kafi, Theodore Schreiber, Lourdes Andaya, Frank A. Baciewicz, Joseph Bassett, Nishit Choksi, Safwan Kassas, Ahmad Munir, Franziska Kothmeier, Annemarie Stroh, Gertrud Goppel, I Hettich, Sabine Bleiziffer, Christian Hengstenberg, A Opitz, Hendrik Ruge, Cătălin Constantin Badiu, Susanne C. Brenner, Yacine Ehlmidi, Ulf Herold, Albert Markus Kasel, Robert Josef Kreuzpointner, Rüdiger Lange, Domenico Mazzitelli, Holger Poppert, Christian Seifert, Dóra Vincze, Bernhard Voß, Krista Camuglia, Dahlia Cowhig, Stephanie P. Newbold, Cynthia Pierce, Samantha Wootton, Sreekanth Vemulapalli, Eric J. Velazquez, James Harrison, G. Chad Hughes, Yasmin Ali, Ali Babi, Adam Banks, Jeffrey G. Gaca, Donald D. Glower, Sankalp Gokhale, Sharif Halim, Robert Hendry, Christian Hernández, Todd L. Kiefer, Michael L. Klein, Brad J. Kolls, Eric J. Marrotte, Andres Pineda Maldonado, Andrew Price, Matthew W. Sherwood, Christa B. Swisher, David Van Wyck, John P. Vavalle, Amit N. Vora, Andrew Wang, Yuriy Zeylikman, Kara Amber, Anne Barnitt, Janet E. Lamm, Lara Mandelstam, Ryan W. Schroeder, Roxanne Sumner, Deepu Nair, Ajanta De, Vincent A. Gaudiani, James D. Joye, Lidia Brown, Christine Hessler, Chad Rammohan, Conrad Vial, Elizabeth S. Charles, Angela DeQuesada, Maria Kaner, Sonya Mathewson, Kristy Pitts, Lauren Wheeler, Ashley Wilson, Estella Davidson, Stephen Frohwein, Stamatios Lerakis, John Merlino, Angela Sullivan, Vasilis Babaliaros, Robert A. Guyton, Vinod H. Thourani, Aaron Anderson, Samir Belagaje, Karima Benameur, Chandan Devireddy, James M. Greene, A Harrison, Kristen Hudson, Bradley G. Leshnower, William Lieppe, Steven Macheers, Kreton Mavromatis, Jeffrey S. Miller, Fadi Nahab, Keith A. Sanders, Eric L. Sarin, James P. Stewart, Daniel Winkel, Liesbeth W. Duininck, Titia Gussinklo, Shashikala Jadoenath-Oedai, Arno Ruiter, Nico van den Berg, Liz E.N. van der Velden-Macauley, Maaike van Huis, S. Verelst, Marcel L. Geleijnse, Wim B. Vletter, Margaretha Bekker, A. Pieter Kappetein, Nicolas M. Van Mieghem, Joseph A. Bekkers, Karla Biesheuvel, Özcan Birim, Goris Bol Raap, Joost Daemen, Peter Paul de Jaegere, Rob de Lind van Wijngaarden, Ladbon Khajeh, Charles Kik, Peter J. Koudstaal, Frans B S Oei, Maaike Scheele, Pieter C. van de Woestijne, Robert‐Jan van Geuns, Wouter J. van Leeuwen, Amy Henderson, Faye Straight, David J. Schneider, Marc E. Tischler, Harold L. Dauerman, Frank Ittleman, Joseph Schmoker, Abraham Abernethy, Imran Alkhalil, Amir Azarbal, Sreedivya Chava, Christopher Commichau, David Coyle, Jan Denkmann, Christine M. DeStephan, Gregory Ehle, Mohamed T. El‐Haddad, Catherine Falduto, Mark Gorman, Sabeeda Kadavath, Bruce J. Leavitt, Allison Mack, Gangadhar Malasana, Shahab Moossavi, Newton Phuong, Mehdi Rambod, Naveen Seecheran, Ashwini Sharma, Edward F. Terrien, Barbara Worgan, Magdalena Zeglin-Sawczuk, Brian Burgess, Susan Killbride, Amy Temple, Joyce Burnside, Christopher Good, Shikhar Agarwal, Alfred S. Casale, Kimberly A. Skelding, Russell Carter, Christopher L. Cummings, Vicente Grana, Carl Haegerl, Kishore J. Harjai, Neil R. Holland, Deepak Singh, Russell F. Stahl, Joseph Stella, Birute Stewart, Douglas Long, Kim Wood, Donna Alexander, S. G. Barton, Elaine Logtens, Anna-Marie Marsh, John McAdam, Jan Kovac, Giovanni Mariscalco, Tomasz Spyt, Soumitra Garimella, J. Szostek, Viktor Zlocha, Lavonda Kirkland, Lori L. Reid, Susan Reilly, Melody Menderhall, William Martin, Steven Park, Puvi Seshiah, J. Michael Smith, Karen Gersch, Loren F. Hiratzka, John Kachoris, Eric Okum, Maria Cardozo, G. Cyr, W. Lane Duvall, Aidan Flynn, Nancy Krupowies, Matthew Parker, Robert Hagberg, Raymond G. McKay, Talhat Azemi, Robert S. Brown, Daniel Fusco, Jonathan Hammond, Catherine Hosley, Francis J. Kiernan, Ronan Margey, Paul Preissler, Immad R. Sadiq, Isaac Silverman, Susan Taboada, David J Underhill, J.M. Escobar, Becky Lopez, Stephanie Mullin, Christine Quesada, Tracy Lawrence, Tasneem Z. Naqvi, Ray Matthews, Vaughn A. Starnes, Leonardo Clavijo, Mark J. Cunningham, May Kim‐Tenser, Nerses Sanossian, David M. Shavelle, Danielle DelMotte, Samantha Henry, JoAnne Moltrassie, Ashish K. Solanki, Raymond Cooper, James T. Lee, Sachin Parikh, Dee Dee Wang, Brian Zweig, William O’Neill, Gaetano Paone, Jamil Borgi, Robert J. Brewer, Marvin H. Eng, Adam B. Greenbaum, Mayra Guerrero, D. Claire Miller, Panayiotis Mitsias, Jeffrey A. Morgan, Hassan Nemeh, Javier Alcaide Muñoz, Maria Medina Fernandez, Fernando Carrasco Chinchilla, Isabel Rodríguez Bailón, José Marı́a Hernández Garcı́a, Miguel Such, Juan H. Alonso‐Briales, Carlos de la Cruz Cosme, Antonio J. Domínguez-Franco, Maria J. Mataró López, José M. Melero, Antonio-Jesus Muñoz-Garcia, Gemma Sánchez Espín, Jose Manuel Fernández Maese, Marta E. Torres, Esther Villa Suarez, Jesús M. de la Hera, Juan Carlos Llosa Cortina, Cesar Morís de la Tassa, Pablo Avanzas Fernández, Lorena Benavente Fernández, S. Calleja, Raquel Del Valle, Carlos Morales Pérez, Jacobo Silva, Eva Bluntschli, Dorothée Keller, Sandra Maritz, Rafael Ruest, Christa Schönenberger, Moreno Trovato, Nicolas Brugger, Volkhard Göber, Reto Kurmann, Sylvia Reineke, Fabian Zürcher, Thierry Carrel, Stephan Windecker, Marcel Arnold, Rupashani Balasubramaniam, Sebastian Bellwald, Morin Beyeler, Anne Broeg, Monika Bühlmann, Lutz Büllesfeld, Lukáš Čapek, Panagiotis Chaloulos-Lakovidis, Noé Corpataux, Lars Englberger, Steffen Gloekler, Martina Beatrice Goldlin, Christoph Huber, Ahmed A. Khattab, Rebekka Kurmann, Jonas Lanz, Kai Liesirova, Basel Maamari, Heinrich P. Mattle, Thomas R. Meinel, Leonidas D Panos, Fabien Praz, Florian Schönhoff, Agnieszka Sleszak, Alessandro Spirito, Stefan Stortecky, Lukas Vaisnora, Rascha von Martial, Peter Wenaweser, Katarzyna Zuk, Iris Musso, Meredith Allen, Michael Gonzales, Ken Horton, John R. Doty, Brian Whisenant, W. Caine, Stephen E. Clayson, James Harkness, Robert Hoesch, Mengjing Huan, K. Jones, Edward Miner, B.B. Reid, Elizabeth Sunderman, Kathleen Citro, Michele Fisher, Judi Willhide, Mary C. Corretti, John V. Conte, Kaushik Mandal, Jon R. Resar, Matthews Chacko, Rani K. Hasan, Barbara Heil, Elizabeth Marsh, Joel Price, Chris Sciortino, Ashish S. Shah, Jennie Tolentino, Anh Bui, Ming Sum Lee, Colin Watanabe, Vicken Aharonian, Naing Moore, Thomas Pfeffer, Zahra Ajani, Prakash Mansukhani, Navdeep Sangha, Kwok L. Yun, Susanne Hylander, Magnus Bäck, Matthias Corbascio, Carl-Gustaf Hillebrant, Andreas Rück, Rodney De Palma, Kari Feldt, Konstantinos Kostulas, Magnus Settergren, Keita Yamasaki, Michelle A. Anderson, Charlotte E. Bloomfield, Natalie Burton-Wood, Charlotte Harland, Kathryn Somers, Tracey L. Ware, Sarah Deakin, Susan Geldard, Dominik Schlosshan, Daniel J. Blackman, Pankaj Kaul, Betsy Evans, Kalyana Javangula, Sameer S. Limaye, Christopher J. Malkin, Peter Wanklyn, Anita Farhi, Arika Manapat, Leandro Maranan, Effe Mihelis, Amelia Ng, Melissa L. 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Speight, Waimai Amy Tai, Inke Albersen, Rebecca Gornelda Bras, Conny Feirabend, Johanna Catharina Helwig-Vernooij, Gerda Kranen, Manfred Oostveen, Ilona Rost, Inge van Deutekom, Atie van Weelden, Robin Heijmen, Jurriën M. ten Berg, Mike Arnoud Ramon Bosschaert, Thomas L. de Kroon, P.H.E. Hilkens, Eliza G. Mast, B. J. W. M. Rensing, W.J. Schonewille, Alberta Nelina van den Akker, Elizabeth Haag, Joan Jennings, Patricia Krug, Lyn Santiago, Sonika Seth, Nellia Dimsuyu, Dennis Mihalatos, George Petrossian, N. Bryce Robinson, Neil Bercow, Andrew E. Berke, Ezra Deutsch, Perry Stevens, Sue Brown, Victor Dos Santos Jardim, Nicole Radford, Venessa Sookhoo, Kojo Kyereme, Rachel Punzalan, Rebecca M. Reynolds, Bogdan Sculeany, Rakesh Sharma, Amanda L. Stuart, Stephen Brecker, Marjan Jahangiri, Aiman Alassa, Venkatachalam Chandrasekaran, Brian Clarke, Cameron Dowling, Barry Moynihan, David Roy, Mazin A.I. Sarsam, Renee Bess, Megan Henkel, Natalie Herbert, Gerald M. 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Deo, Jennifer Anderson, Kyle Greening, Jodi Karson, Susie Page, Tilitha Shawgo, Jon C. Freeman, Kevin Mulhern, Jayant Nath, Peter Tadros, George L. Zorn, Eric Hockstad, Colleen Lechtenberg, Gregory Muehlebach, Michael Rippee, Lee Rosterman, Jayashree Sundararajan, Yunxia Wang, Mark Wiley, Suresh Atapattu, Christian Marin y Kall, Maureen H. Lowery, Eduardo de Marchena, Tomás A. Salerno, Carlos Alfonso, Roger Carillo, Alexandre Ferreira, Anthony L. Panos, José G. Romano, Donald Williams, Shradha Bhatt, Erin M. Migda, Jessica Oakley, Wendy Warshal, Sandra Wilcock, Anna M. Booher, Troy LaBounty, Stanley Chetcuti, G. Michael Deeb, Eric E. Adelman, Mary Jo Boyle, Rachel Geml, Paul Grossman, Danielle Guerin, Kelley Hodges, Karen Kim, Deborah Lammers, Mollie McDermott, Daniel Menees, Robert Pace, Himanshu J. Patel, Richard L. Prager, Sindhu Ramchandren, Matthew Romano, Angela Stamper, Michael Wang, Darin B. 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Narins, Thomas Stuver, Kathy Adams, Lynn Blair-Anton, Mary Lou Haynes, Carol Watts, Michael Baker, Lisa A. Mendes, Stephen J. Ball, Kashish Goel, Clayton A. Kaiser, Mark Robbins, David Zhao, Rashid Ahmad, Marshall Crenshaw, Joseph L. Fredi, Lisa Hermann, Steven J. Hoff, Howard S. Kirshner, Melissa M. Levack, Shilpi Mittal, Anne E O’Duffy, Michael R. Petracek, Judy Baer, Grace Liang, Son Nguyen, Paul A. Heidenreich, Patricia K. Nguyen, Thomas A. Burdon, John C. Giacomini, Celina M. Yong, Maurice Buchbinder, James I. Fann, Shannon M. Kilgore, R. Scott Mitchell, Sharon S. McDaniel, Angelina Pack, Wendi White, Travis S. Young, Pam Burgess, Min Pu, Bharathi Upadhya, Robert J. Applegate, Neal D. Kon, Martinson Arnan, Sanam Baghshomali, L. R. Bishop, Edward Bradbury, Sanjay Gandhi, Edward H. 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Importance: In patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited. Objective: To report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial. Design, Setting, and Participants: SURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021. Intervention: Patients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis. Main Outcomes and Measures: The prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years. Results: A total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention. Conclusions and Relevance: Among intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.